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Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: September 26, 2007
Last updated: November 26, 2012
Last verified: November 2012
This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Mesothelioma Drug: LBH589 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IB, Open-Label, Multicenter Study to Investigate the Effect of Oral LBH589 on Dextromethorphan, a CYP2D6 Substrate, and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Pharmacokinetic (PK) parameters [ Time Frame: first 10 days ]

Secondary Outcome Measures:
  • Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs) [ Time Frame: day 10 through end of treatment ]
  • Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation [ Time Frame: first 10 days, day 10 through end of treatment plus follow-up ]
  • Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation [ Time Frame: day 10 through end of treatment ]

Enrollment: 18
Study Start Date: November 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LBH589 Drug: LBH589


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Age ≥ 18 years
  2. Must have histologically or cytologically confirmed advanced or metastatic incurable solid tumor as documented by CT or MRI that has progressed on or following standard therapies
  3. Must have failed prior standard systemic therapy
  4. Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
  5. Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
  6. Written informed consent obtained prior to any screening procedures
  7. Willingness to have multiple blood draws
  8. Ability to swallow capsules or tablets

Exclusion criteria:

  1. Uncontrolled brain metastases
  2. Prior treatment with an HDAC inhibitor
  3. Presence of clinically detectable third-space fluid collections (e.g., ascites or pleural effusions) that can not be controlled by drainage or other procedures prior to study entry
  4. Concomitant use of any anti-cancer therapy, including radiation therapy
  5. Significant cardiac disease
  6. Concomitant use of drugs with a risk of causing torsades de pointes
  7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
  8. Previous use of monoamine oxidase inhibitors (e.g. clorgyline, iproniazid, isocarboxazid, moclobemide, sibutramine, phenelzine, tranylcypromine) within 14 days prior to the first dose of dextromethorphan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00535951

United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
RUSH Medical Center
Chicago, Illinois, United States, 60612
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Novartis Investigative Site
Ontario, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00535951     History of Changes
Other Study ID Numbers: CLBH589B2109
Study First Received: September 26, 2007
Last Updated: November 26, 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Non-small cell lung cancer
lung cancer
pleural mesothelioma
advanced stage
phase I

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on September 20, 2017